All documents shown here are included in the seminar for instant download

Analytical tools for Characterization of Biotechnology Products and Processes
(link)

Learn from FDA Warning Letters what inspectors look for and what
mistakes other companies make so you can avoid them

Labcompliance On-line Audio Seminar

This seminar has been recorded and is
available on CD and for instant download. All reference material as
listed below and more is available on a special seminar website. The
website is regularly updated with most recent information. In case
there are questions related to the topic, they can be submitted
through a web form and will be answered by the speaker. For ordering
info
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On-line Audio Seminar 268

FDA Compliance for Biopharmaceutical
Laboratories

Become familiar with FDA regulations and
get tool kits for implementation

Recorded, available with the reference material
at any time

There is a clear trend In the pharmaceutical industry from small to large
molecule based drugs. With the move of drugs from research to development and
manufacturing compliance becomes more and more important. Scientists and and
analysts working in biopharmaceutical laboratories should be aware of
specific requirements . US and most international countries have regulations
with specific sections for laboratories. However, regulations only tell you what
to do but not how to implement. So there are many questions.

Key Questions related to Regulated Biopharmaceutical are:

What are the most important FDA and international
regulations and guidelines?

When in drug product developments does each regulation
apply?

Is drug discovery regulated?

What are the key differences between regulated and
non-regulated laboratories?

Which procedures do we need?

Which laboratory records should be retained for how long?

What and how to validate methods and qualify equiment

How to most effectively implement compliance on
laboratories?

How to best prepare for FDA inspections

What are the incremental costs of compliance?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. This semimar is intended to introduce
biochemists and biologists working in biopharmaceutical development
and quality control laboratories to FDA and equivalent international
requirements. It is also useful for quality managers and staff and
for everybody else involved in the registration process of
biopharmaceuticals. The seminar will also give strategies and
specific recommendations for regulated laboratories. In addition
attendees will get tool kits for effective implementation. ..

During the interactive presentation you learn about:

Key difference between regulated and non-regulated
laboratories

The most important regulations and guidelines related to
biopharmaceutical laboratories

The compliance "hot-spots" the FDA investigators look for
during inspections

Regulations as they apply to different lifecycle phases:
GLP, GCP, cGMP

Requirements along the sample workflow, from sampling to
testing, data evaluation, reporting and data archiving

Qualification of equipment and validation of analytical
methods

Eight essential steps for effective implementation

Internal audits as an ideal preparation for FDA inspections

Incremental Costs of Compliance

And for easy and instant implementation:
download 10+ documents from special seminar website

About audio seminars

Online audio seminars are presented over the
phone. During the live presentation attendees can:

Study the printed slide material

Watch the slides on a computer

Watch the slides on a video screen in a seminar room

Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
agencies.

Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,
click here.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith,
FDA's national Part11 expert, at a panel discussion with
Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about
computer system validation and e-records.